Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System.

Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector's independence.